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Regulatory
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FDA Orange Book

US FDA letting FTC decide if Orange Book listings ‘improper’

Nov. 17, 2023
By Mari Serebrov
The U.S. FTC’s policing of Orange Book patent listings begs the question of when, and whether, the FDA will deliver on its commitment to provide more clarity on the types of device patents that can be listed as covering a “drug product.”
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Genitourinary/Sexual Function

Kanna Health’s KH-001 for premature ejaculation cleared to enter clinic

Nov. 17, 2023
Kanna Health Ltd. has received clearances by the FDA and the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) for its IND application and clinical trial application (CTA), respectively, to initiate a first-in-human phase I trial of KH-001 besylate (KH-001) for premature ejaculation.
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Red blood cells, DNA

Historic MHRA exa-cel win bagged, Crispr/Vertex await FDA nod

Nov. 16, 2023
By Randy Osborne
With a landmark U.K. approval in hand for Casgevy (exagamglogene autotemcel [exa-cel]) to treat sickle cell disease and transfusion-dependent beta thalassemia, Crispr Therapeutics AG and partner Vertex Therapeutics Inc. are turning their attention to the PDUFA dates set by the U.S. FDA for the treatment in both conditions.
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Overcoming two CRLs, Cormedix’s catheter solution is FDA approved

Nov. 16, 2023
By Lee Landenberger
After Cormedix Inc. navigated manufacturing issues that slowed the process, the U.S. FDA approved the antibacterial and antifungal solution Defencath to reduce catheter-related bloodstream infections adults with kidney failure.
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FDA icons and doctor

US FDA: Withdrawal not an option for outlier lymphoma drugs

Nov. 16, 2023
By Mari Serebrov
From the start of the Nov. 16 Oncologic Drugs Advisory Committee meeting, the U.S. FDA made it clear that withdrawing Acrotech Biopharma Inc.’s peripheral T-cell lymphoma drugs, Folotyn (pralatrexate) and Beleodaq (belinostat), from the market until a long-overdue confirmatory trial is completed is not an option given the current treatment landscape.
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Augtyro US FDA-approved for ROS1+ non-small-cell lung cancer

Nov. 16, 2023
By Karen Carey
More than a week earlier than its PDUFA date, Bristol Myers Squibb Co. received U.S. FDA approval of its next-generation ROS1 tyrosine kinase inhibitor repotrectinib for adults with ROS1-positive locally advanced or metastatic non-small-cell lung cancer.
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U.S. Capitol and $100 bills

US House subcommittee kicks breakthrough device coverage into gear

Nov. 16, 2023
By Mark McCarty
Medical device companies and trade associations alike have been clamoring for some time for a leaner path to Medicare coverage for their more novel product offerings, a message that may be gaining traction.
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Art concept for gene therapy research
2023 Artificial Intelligence Summit

Uncertainty drives concerns over bias risk in artificial intelligence

Nov. 16, 2023
By Mark McCarty
The U.S. FDA’s approach to bias covers a large swath of territory, including the potential for bias to creep invisibly into artificial intelligence (AI) products. Yarmela Pavlovic, vice president for global regulatory affairs at Medtronic plc, said at this year’s Artificial Intelligence Summit that regulators may be more wary of the potential hazards of bias in AI compared to non-AI software simply because of the difficulty in anticipating how bias might affect the function of these advanced algorithms.
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Regulatory actions for Nov. 16, 2023

Nov. 16, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Boston Scientific, Cormedix.
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Macrophage illustration
Immuno-oncology

Sirpant-M granted US orphan drug designation for T-cell lymphoma

Nov. 16, 2023
Sirpant Immunotherapeutics Inc.’s lead product candidate, Sirpant-M (SI-101), has been awarded U.S. orphan drug designation for the treatment of T-cell lymphoma.
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